Compositions and methods of treatment with amniotic fluid

Abstract

The present disclosure provides compositions composed of amniotic fluid and/or modified amniotic fluid, a pharmaceutically acceptable carrier, and optionally a placental tissue graft, micronized placental tissue components, or extracts derived therefrom. Also described are systems and apparatuses for administering or storing said compositions, as well as methods of treatment using said compositions.

What is claimed is: 
     
       1. A composition comprising an amount of modified amniotic fluid wherein said amniotic fluid is sterilized and desalted;
 wherein the modified amniotic fluid has been desalted to remove all or substantially all salts; or 
 wherein the modified amniotic fluid has a salt concentration of 0.9% saline +/−0.1%. 
 
     
     
       2. The composition of  claim 1 , wherein the modified amniotic fluid is free or substantially free of material greater than 1 μm in size. 
     
     
       3. The composition of  claim 1 , wherein the modified amniotic fluid is human amniotic fluid. 
     
     
       4. The composition of  claim 1 , wherein the modified amniotic fluid is free or substantially free of cells and/or cellular debris. 
     
     
       5. The composition of  claim 1 , further comprising a pharmaceutically acceptable carrier. 
     
     
       6. The composition of  claim 5 , wherein the modified amniotic fluid and pharmaceutically acceptable carrier have a weight ratio in the range between 1:10 and 10:1. 
     
     
       7. The composition of  claim 5 , wherein the pharmaceutically acceptable carrier is Wharton's jelly, a biocompatible gelation agent, a polysaccharide, hyaluronic acid, poly-1-lysine, or collagen. 
     
     
       8. The composition of  claim 1 , wherein the composition is injectable; is a topical composition; or is a liquid, gel, or paste. 
     
     
       9. The composition of  claim 1 , wherein the composition is a sprayable composition. 
     
     
       10. A solid pellet comprising a dried droplet of the composition of  claim 1 . 
     
     
       11. A molded composition comprising an amount of the composition of  claim 1  dried in a mold. 
     
     
       12. A composition comprising an amount of the composition of  claim 1  and a placental tissue graft. 
     
     
       13. A composition comprising an amount of the composition of  claim 1  and an amount of micronized placental tissue particles. 
     
     
       14. A method for treating a gastrointestinal disease or disorder, a skin disease or disorder, a pulmonary disease or disorder, the method comprising administering to a patient in need thereof an amount of a composition comprising an amount of modified amniotic fluid wherein said amniotic fluid is sterilized and desalted;
 wherein the modified amniotic fluid has been desalted to remove all or substantially all salts; or 
 wherein the modified amniotic fluid has a salt concentration of 0.9% saline +/−0.1%. 
 
     
     
       15. A method for treating a patient who has undergone a cosmetic procedure, the method comprising administering to the patient an effective amount of a composition comprising an amount of modified amniotic fluid wherein said amniotic fluid is sterilized and desalted;
 wherein the modified amniotic fluid has been desalted to remove all or substantially all salts; or 
 wherein the modified amniotic fluid has a salt concentration of 0.9% saline +/−0.1%. 
 
     
     
       16. A method for preventing or reducing scar formation on the spine or near the spine, or sealing a dural tear, or for treating or preventing an anterior procedure or a modified anterior procedure, the method comprising administering to a patient in need thereof an effective amount of a composition comprising an amount of modified amniotic fluid wherein said amniotic fluid is sterilized and desalted;
 wherein the modified amniotic fluid has been desalted to remove all or substantially all salts; or 
 wherein the modified amniotic fluid has a salt concentration of 0.9% saline +/−0.1%. 
 
     
     
       17. A method for enhancing wound healing or preventing scar formation as a result of a surgical incision, or for reducing the amount of scar tissue in a reproductive system after a surgical procedure, the method comprising administering to a patient in need thereof an effective amount of a composition comprising an amount of modified amniotic fluid wherein said amniotic fluid is sterilized and desalted;
 wherein the modified amniotic fluid has been desalted to remove all or substantially all salts; or 
 wherein the modified amniotic fluid has a salt concentration of 0.9% saline +/−0.1%. 
 
     
     
       18. The composition of  claim 1 , wherein the modified amniotic fluid has been desalted to remove all or substantially all salts. 
     
     
       19. The composition of  claim 1 , wherein the modified amniotic fluid has a salt concentration of 0.9% saline +/−0.1%.